Onyx Radiotherapy complex based on a linear electron accelerator

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• Medical Equipment (Global Market)
• Medical Equipment (Russian Market)
• Cancer treatment

2022

Onyx Radiotherapy Complexes Launch

September 29, 2022 it became known about the launch of the production of Russian radiation therapy complexes "Onyx."

Production facilities, their scientific and design support, as well as licensing and marketing support from Rusatom Healthcare, according to the company's representatives, are able to fill the shortage of linear accelerators in Russia and make high-tech oncological assistance more accessible to the population.

Onyx Radiotherapy Complex
Photo: NIITFA

According to Rosstat data for 2021, a total Russia of 262 devices were in operation, while a significant part of such equipment is outdated: 71 linear accelerators have a service life of more than ten years and require replacement. And if you follow the order Ministry of Health of Russia "On approval of the Procedure medical for providing assistance to the adult population in cancer" N 116 of 19.02.2021 to the country , you must have 1 linear accelerator per 300 thousand population. That is, a total of at least 485 devices of this purpose.

For many years, they solved this problem in a well-known way: the regions knocked out funds from the federal budget, announced tenders and over and over again purchased imported devices. In 2020-2021, a large volume of purchases was also carried out under targeted programs - about 90 linear accelerators were installed, including instead of outdated and dismantled equipment.

As of September 2022, according to unofficial estimates, the need for linear accelerators is at least 200 devices.

As noted, the Russian development, which received a registration certificate from Roszdravnadzor, may be in demand. It will cost significantly less than foreign counterparts, which on average cost $3 million - the price varies depending on the configuration. The basic version and the modules for it, so that clinics have a choice, will cost three times cheaper. The basic version can be useful in district dispensaries, and in regional cancer centers and scientific institutes they will probably want to have a full set of functions.

Onyx allows patients to be treated using modern methods of remote radiation therapy: three-dimensional conformal, using imaging tools to control the patient's position, with intensity modulation, rotation with volumetric modulation of beam intensity, etc. Unlike imported counterparts, it does not require high operating costs.

According to the head of Rusatom Healthcare, Igor Obrubov the share of domestic components in the Onyx complex reaches 80%. It is also important that the price of the installation does not depend on the volatility of the exchange rate. And the service and warranty service are provided by specialists. NIITFA^[1]

Registration certificate for the radiation therapy complex based on the Onyx electron accelerator

On July 29, 2022, the company Rusatom Healthcare"" announced Zdrav.Expert the training of a marketing authorization Roszdravnadzor for a radiation therapy complex based on the Onyx electron accelerator - 6 MeV (KLT-6). The first deliveries medical equipment to medical institutions will begin in 2023.

Rosatom received a registration certificate for a complex of radiation therapy for the treatment of cancer

According to the company, the Onyx developer is the Scientific Research Institute of Technical Physics and Automation, which is part of the management loop of Rusatom Healthcare JSC, a division of Rosatom State Corporation.

In the Russian Federation, according to Rosstat for 2021, 262 devices were in operation, while a significant part of the existing fleet of equipment is outdated - 71 linear accelerators have a service life of more than 10 years and require replacement. At the same time, the need for linear accelerators in the country is high. So, in accordance with the order of the Ministry of Health of Russia "On the approval of the Procedure for the provision of medical care to the adult population for cancer" No. 116 of 19.02.2021, it is necessary to have 1 linear accelerator in the country per 300 thousand population, that is, at least 485 devices of this purpose.

In 2020-2021, a large volume of purchases of this equipment remained due to the implementation of targeted programs, about 90 more linear accelerators were installed, including instead of outdated and dismantled equipment. Despite this, the need for linear accelerators is at least 200 devices.

The Onyx radiation therapy complex was created on the basis of a compact medical linear accelerator with a brake radiation beam with a nominal energy of 6 MeV - in most cases such energy is enough for radiation therapy, moreover, it reduces the requirements for the protection of premises and personnel from radiation.

Onyx implements modern methods of remote radiation therapy (three-dimensional conformal, using imaging tools to control the patient's position, with intensity modulation, rotational with volumetric modulation of beam intensity, etc.) in the treatment of patients in radiological departments of oncological institutions of all levels.

Compared to analogues, this complex is characterized by low operating costs while maintaining reliability, greater availability of the service service and domestic components throughout the entire life cycle of the equipment, emphasized in the "Rusatom Healthcare."

As of July 2022, Russia is treating a number of oncological diseases using foreign-made equipment. Onyx is a completely Russian development. The share of domestic components reaches 80%. At the same time, the price of Onyx does not depend on the volatility of the exchange rate. Service and warranty service is provided by JSC NIITFA in Moscow, which ensures proper service speed. told Igor Obrubov, General Director of Rusatom Healthcare

The Rusatom Healthcare division begins mass production of medical equipment. The first deliveries of the radiation therapy complex based on the Onyx electron accelerator to medical institutions are scheduled for 2023.

2020: Principle of operation of the Onyx complex

As of April 2020, the Rusatom Healthcare company, which is part of the Rosatom state corporation, has been working on the Onyx apparatus, a complex for radiation therapy of malignant tumors, for two years. Radiation therapy, along with surgery and chemotherapy, refers to the main methods of combating severe illness.

According to statistics, radiation therapy (including in combination with surgery and chemotherapy) is indicated by 60% of cancer patients, and the need for devices - 1 unit per 300 thousand population. Sadly, according to modern estimates, there is a 50 − 70 percent shortage of the required equipment in Russian clinics, and what is is often outdated and does not use modern technological advances in this area. The task of the creators of the Onyx apparatus is to provide Russian healthcare with an installation that will be cheaper than analogues from eminent foreign competitors, but at the same time will be able to provide therapy at the most modern level.

The basic principle of the device is quite simple: the tumor is "fired upon" by a stream of high-energy photons. As a result of their exposure, free electrons are released in tissues, which ionize the atoms of the environment and destroy the DNA of cancer cells, which leads to the cessation of their proliferation and gradual death. In order to defeat malicious cells and cause minimal damage to healthy tissues, a very complex and expensive design is created. During the therapy session, the beam runs around the patient's body lying on the table, shelling the tumor from different angles. As a result, the maximum dose of radiation is concentrated precisely in the tumor, and healthy tissues are significantly less affected.

Often, the DNA of healthy cells also suffers. However, especially when one of the DNA helices is intact, normal cells are able to recover (this process is called repair), and tumor cells have much less potential for repair. To achieve an accurate effect on the tumor, which is often small in size), it is necessary that the radiating head be mounted on a precision-rotating structure called a gantry. Gantry has a mass of about a ton. When collecting the Onyx experimental sample, we were concerned about whether we would be able to achieve the necessary accuracy in the calculation, design and manufacture of the structure. For normal operation of the device, it is required that the virtual center of rotation of the gantry during operation does not shift by more than 1 mm. Our fears were in vain: the maximum deviation was only 0.3 mm. told Tatyana Krylova, Onyx project manager

The central element of the Onyx, mounted inside the gantry, is an electron gun with a linear electron accelerator. The accelerator was developed exclusively by Russian specialists and, due to the special structure of the internal cells, has a length of only 30 cm (versus 40 cm for analogues). The high-frequency power required by the accelerator is supplied by klystron - a device that, compared to another microwave source - magnetron - provides greater stability and high beam power.

Until now, it was about photon radiation, and now it's about an electron gun. The electron beam does not go directly to the body, but hits a target 3 − 4 mm thick. Electrons give their energy to the target, inhibitory radiation occurs, which in the form of photons rushes further and meets two important devices on its way. One of them is an ionization chamber that measures the dose of radiation in order to track its presence in the specified parameters. The second is a collimator. "Onyx" is able to irradiate an area of ​ ​ 40 x 40 cm. In practice, a much narrower beam is needed, which has not square outlines, but precisely in the shape of the tumor. The collimator is a rather complex device that, with the help of thin tungsten petals, creates, as it were, a template that gives the beam of particles the desired shape.

Before the patient enters the course of radiation therapy, he is prescribed a study using a device computed tomography (3D X-ray study). Then, in the resulting image, the doctor notes the contours of the tumor and nearby vital organs (lungs, heart spinal cord, etc.) and determines which radiation doses should be applied to which area. A medical physicist working in tandem with a doctor (there is such a specialty) using a dosimetric planning system calculates the beam parameters and exposure time necessary to implement the task set by the doctor. The resulting treatment plan is transferred to Onyx and processed ON - the treatment plan medical in the format DICOM must be translated into language. electronic engineers

Accurate-to-target irradiation is provided not only by the precision operation of the gantry and multi-lobe collimator, but also by a movable table with six degrees of freedom coordinated to the entire device. The table automatically positions the lying patient so that the device shines where it is necessary, without deviating by a millimeter. On the Onyx scheme, you can see another additional control system - a kind of retractable "hands," in one of which there is a source of X-ray radiation, and in the other - a detector. Thanks to cone-beam computed tomography, it is possible to obtain a fairly detailed picture of how the tumor is located relative to the therapeutic beam before the radiation session.

Components of the experimental sample

• 1. Accelerator system: a) klystron; b) waveguide; c) accelerating structure
• 2. Radiation head includes primary collimator, leveling filter, ionization chamber and collimator shutters
• 3. Rotary Support Device
• 4.KV imaging system (X-ray emitter and detector) KV imaging system (X-ray emitter and detector)

In the device, a prototype of which we have created, we have collected almost all modern technologies available in foreign counterparts. Many of the nodes have been developed directly in our country, others (for example, a collimator and a 6D table) are still imported, but in the near future JSC NIITFA, together with MOKB Mars, which is also part of our structure, should create domestic samples. And of course, Onyx will be cheaper than imported installations of this class. 2020 will be devoted to the revision of both software and hardware and the passage of technical tests, and in 2021 we plan to begin the procedure for obtaining a registration certificate for a medical device. told Tatyana Krylova, Onyx project manager

2019

Plans to bring the Onyx accelerator to clinical trials at the end of 2020

On November 28, 2019, Zdrav.Expert learned that the Russian accelerator for photon radiation therapy Onyx (KLT-6) with a capacity of 6 MeV will be released for clinical trials at the end of 2020. Vladimir Lazarev, director of interaction with state authorities of Rusatom Healthcare JSC, spoke about this.

NIITFA (Research Institute of Technical Physics and Automation) came close to producing a model of a linear 6 MeV radiation therapy apparatus under the Onyx brand. In 2020, clinical trials will be carried out, and in 2021 we plan to release it in series on the Russian market , Lazarev stated

As explained in NIITFA, the complex is based on a 6 MeV accelerator, while the energy in it can vary from 2.5 MeV to 6 MeV. Energy of 2.5 MeV will be used to visualization reduce the dose burden on the patient. In terms of its technical characteristics, the device will not be inferior to modern foreign complexes with 3D visualization. Most of the parts used in Onyx are domestic production. Foreign components are still detectors of a kilovolt radiation source, an accelerator section modulator, a therapeutic table and a multi-lobe collimator. The last two nodes in 2020 are planned to be replaced by Russian ones, developed at the beginning of December 2019 by NIITFA together with the Mars Design Bureau (part of the GC circuit Rosatom"").

On November 28, 2019, an experimental sample was collected at the institute, which at the end of December 2019 is planned to be installed in the canyon for research tests.

At the end of December, we must say that there is an experimental sample, and begin to collect a prototype, which will undergo further technical and clinical trials for registration. At the end of 2020, we must pass all technical tests with a prototype and begin clinical research. The end of 2021 is the beginning of production. In parallel with the development of a single sample, we are creating an assembly site on the territory of NIITFA, and then small-scale production, explained representatives of NIITFA

The tender for R&D to create and transfer to clinical trials "a sample of an import-substituting radiation therapy complex based on innovative equipment" - 6 MeV accelerator and cone-beam tomograph - was announced by the Ministry of Education and Science in October 2017. The contractor of the project was JSC NIITFA, the total amount of financing from 2017 to 2019 is 250 million rubles. In addition to the head institute, a working group of specialists of Rosatom State Corporation, the National Medical Research Center of Radiology of the Ministry of Health, the N.N. Blokhin National Medical Research Center of Oncology, Moscow State University and MEPhI takes part in the development. According to the terms of the R&D contract, the work should be completed in June 2020.

In February 2019 Ministry of Health RUSSIAN FEDERATION , he approved a list medical of equipment designed to re-equip clinics under the oncological national project program "." The Health care list as of November 28, 2019 includes 147 items, medical products including heavy equipment -, and CT PET MRI. The Ministry of Health recommended that the regions purchase medical products from domestic manufacturers at the expense of the national project budget with "equivalent technological characteristics."

In the spring of 2019, Alexei R-Pharm Repik's group, RTT Factory LLC, began assembling linear accelerators from American the manufacturer of medical equipment Varian Inc. In September 2019, the parties agreed to localize the latest version of the major linear accelerators Halcyon in addition to Unique and Clinac, which are already being assembled in Dubna near Moscow^[2]

Presentation of linear accelerator for remote radiotherapy

On September 24, 2019, TAdviser learned that Rusatom Healthcare (an enterprise of ROSATOM State Corporation) had demonstrated a linear accelerator preparing for production at the Research Institute of Technical Physics and Automation (NIITFA).

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Such devices are the main component of departments for remote radiation therapy. They make it possible to implement the most modern methods of radiation therapy - personalized treatment with bringing the maximum dose of radiation to the neoplasm and minimizing dose loads on the surrounding healthy tissues and organs.

According to Alexander Shibanov, General Director of Rusatom Healthcare JSC, the radiotherapy system being developed is not only a medical accelerator, but a multi-component software and hardware complex that also contains a dosimetric planning system for calculating radiation plans and an oncological information system. Thus, when Onyx is delivered to radiological departments, doctors will receive a working system that does not require understaffing with separate modules and parts. A single integrated digital platform will become universal for other further developments in the field of radiation therapy, he said.

By December 2019, it is planned to collect an experimental sample of the complex. Thus, the stage of applied scientific research and experimental development will be completed and the stage of creating a prototype of the complex will begin. It is expected to become clinical after passing all the required tests in 2021^[3].

2018: Launch date determined

Rosatom State Corporation intends to bring to the market in 2022 an import-substituting radiotherapy complex based on a linear electron accelerator with an energy of 6 MeV, designed for accurate, so-called precision radiation therapy of malignant tumors. The relevant plans of Rosatom are stated in the report published by the state corporation in 2017. According to the authors of the document, the device will reduce "the costs of medical institutions for the purchase and maintenance of equipment for radiation therapy."

As follows from the report, financial support for the project is provided by the Ministry of Education and Science of the Russian Federation. At the same time, the amount of funding was not disclosed.

A consortium of enterprises led by NIITFA is developing a domestic radiotherapy complex based on a linear electron accelerator with an energy of 6 MeV. Photo: privatemedicalclub.com

It is assumed that after putting into production and registration as a medical device, the proposed complex of radiation therapy will reduce import dependence in the field of equipping domestic healthcare with modern medical equipment. At the same time, mass production and availability of the domestic complex will also allow medical institutions to improve the quality of treatment of cancer patients, according to Rosatom.

According to the academician Andrey Kaprin of the general director, NMICR Ministry of Health Russia medical specialists throughout Russia, as of 2018, there are approximately 300 linear accelerators for 6 MeV.

According to the document, a whole consortium of enterprises under the leadership of the Research Institute of Technical Physics and Automation (NIITFA) is engaged in the creation of the complex. Co-executors are the National Research Nuclear University MEPhI, the National Medical Research Center of Radiology (NMITR) of the Ministry of Health of Russia, the Laboratory of Electronic Accelerators of Lomonosov Moscow State University and Radiation and Oncological Intelligent Systems and Services. The industrial partner of the project was the company "Rusatom Healthcare" - an integrator in the field of radiation technologies for medicine and industry "Rosatom."^[4]

In general, Rosatom expects to implement the project in 2.5 years. A pilot sample of the radiotherapy complex will be ready presumably in 2020.^[5]

2017: First stage of works completed

At the end of 2017, the Research Institute of Technical Physics and Automation (NIITFA) completed the first stage of the project to create a radiotherapy complex based on a linear electron accelerator with an energy of 6 MeV.

The device, called "Onyx," is the first domestic development of this kind. In addition to NIITFA JSC, which is the lead contractor, LEU,, MSU NRNU MEPHI FSBI NMIRC, MINISTRY OF HEALTH RUSSIAN FEDERATION"" and "" participate in the project. Karfidov LabPeacock Technologies At the stage of creating a prototype, the Mars MOKB will also enter into cooperation, thanks to which the percentage of imported components will become even smaller - a domestic therapeutic table and a multi-lobe collimator will be developed.

Notes